VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 2 of 3 Acquisition ID# 36C262-26-AP-3646 receptor-targeted radioactive diagnostic agent used for sentinel lymph node biopsy and lymphatic mapping in solid tumor patients. When a patient has surgery to remove the culprit tumor, it is imperative to find the sentinel node (first node in a lymphatic chain) to determine if the cancer has spread. Lymphoseek goes to the sentinel node by active receptor targeting (CD206 receptor), which gives reliable stability, never separates from the receptor, and only the radioactivity will fade away.

Since Lymphoseek is a receptor target specific, there is a lack of progression to the other nodes in the nodal chain, which allows more accurate information of the sentinel node in the Nuclear Medicine scans. The location of this node is communicated to the surgeon, who will be able to find it during surgery the following day. Other agents, such as filtered sulfur colloid, separate from the receptor. These agents have a mechanism of action based on particle size and phagocytosis (gathering large particles by lymphatics), which is less effective. Lymphoseek has its superior ability of targeting the active receptor and allows the drug to stay in only that receptor and the radioactivity to fade away. Lymphoseek provides the most superior image quality localizing involved lymph nodes in patients.

Cardinal Health 414, LLC is the only responsible source for the required Lymphoseek that is highly specialized. Any substitute for this radioactive drug will directly affect patient care at VA medical centers. Navidea Biopharmaceuticals Inc.

is the patent owner for Lymphoseek; however, Navidea granted Cardinal Health exclusive licenses to manufacture and commercialize Lymphoseek in North America, which makes Cardinal the only responsible source. Cardinal Health 414, LLC has successfully delivered and fulfilled similar requirements at multiple VA Medical Centers in VISN 22 in the past. This requirement can be only fulfilled by Cardinal Health 414, LLC.

4. Description of market research conducted and results or statement why it was not conducted: Small Business Administration (SBA)’s Small Business Search (SBS) was utilized to identify potential SD/VOSBs who can compete for this requirement. SBS returned 188 SD/VOSBs registered under NAICS code 325412.

However, identified SD/VSOBs do not have capabilities to manufacture or distribute Lymphoseek as it is a proprietary radioactive agent.

VA National Acquisition Center (NAC) Pharmaceutica Catalog was reviewed if the requested radioactive agent is available from the established Federal Supply Schedule. But no related result was returned.

NCO 22 has procured the radiopharmaceutical Lymphoseek in the past; therefore, past contract actions and its market research were reviewed. VA Long Beach Healthcare System Radiology service has an indefinite delivery indefinite quantity (IDIQ) contract 36C26225D0035 in place to procure Lymphoseek with Cardinal Health 414, LLC for base plus option four years. The total estimated contract value of this IDIQ is . And this contract was executed using other than full and open competition in accordance with FAR (prior to RFO).

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID# 36C262-26-AP-3646

A special notice, an intent to sole source, was posted on SAM.gov to survey if there are compatible radiopharmaceutical and/or capable contractors who can fulfill this requirement. The notice was posted on 2/26/26 through 3/5/26; however, no response was received. This verifies that Cardinal Health 414, LLC is indeed the sole source of Lymphoseek. Cardinal Health 414, LLC also provided a letter stating that they have exclusive rights to manufacture and distribute Lymphoseek in the United States. The contracting officer has also verified and confirmed that Cardinal Health 414, LLC indeed holds exclusive licenses via online search engines. The market research conducted confirms that Cardinal Health 414, LLC is the sole source who can fulfill this requirement.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR

). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

NCO 22